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Trial Title:
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
NCT ID:
NCT05673746
Condition:
Peripheral Neuropathy
Conditions: Official terms:
Peripheral Nervous System Diseases
Conditions: Keywords:
peripheral neuropathy
breast cancer
acupuncture
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Acupuncture
Description:
acupuncture administration
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
treatment of physician choice, according to the standard of care
Description:
treatment of physician choice, according to the standard of care for the treatment of
chemotherapy-induced peripheral neuropathy, including neuropathic pain
Arm group label:
Arm A
Arm group label:
Arm B
Summary:
The main purpose of this study is to define whether acupuncture in addition to the
treatment of physician choice as per standard of care leads to a greater decrease of
neuropathic pain as perceived by women with breast cancer who suffer from
chemotherapy-induced peripheral neuropathy. Peripheral neuropathy and neuropathic pain of
hands and foots will be assessed by using a Number Rate Scale (NRS scale) and data will
be compared between standard of care treatment group and acupuncture in addition to
standard of care treatment group.
Detailed description:
Patients with breast cancer diagnosis and taxane-induced peripheral neuropathy since at
least 1 week (CTCAE4.0 Grade 1-3 and NRS≥4) will be enrolled. Patients will be randomized
1:1 in the 2 treatment arms: treatment of physician choice as per standard of care vs
acupuncture in addition to standard of care treatment. In experimental arm acupuncture
will be performed twice a week for 6 weeks, for a total of 12 sessions. Peripheral
neuropathy symptoms and pain at hands and foot will be recorded every day by patients by
use of NRS scale. At baseline and every 3 weeks patients will complete CIPN20, EORTC
QL30, SF-36 and BPI in order to compare the course of neuropathic pain and quality of
life in the 2 arms.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female patients ≥18 years.
- Patients with diagnosis of breast cancer (stage I-III) currently receiving
taxane-based chemotherapy (paclitaxel or docetaxel) in neoadjuvant or adjuvant
setting, or who have completed taxane-based chemotherapy for no more than 6 months.
Concomitant treatment with trastuzumab is allowed in HER-positive patients and/or
hormone therapy in patients with hormone-sensitive breast cancer.
- Chemotherapy-induced peripheral neuropathy graded 1-3, according to NCICTCAE v 4.03
criteria, for at least one week and for no more than 6 months after the completion
of chemotherapy regimen.
- Neuropathic pain with ≥4 points in the numeric scale rate for at least one week
- Informed consent signed before any study-specific procedure
Exclusion Criteria:
- Patients with diagnosis of metastatic breast cancer
- Pre-existing peripheral neuropathy in the 28-day period before the start of
chemotherapy
- Any pre-existing condition which can both lead to or be a concomitant factor for
neuropathy onset, such as not controlled diabetes mellitus, paralysis, multiple
sclerosis, AIDS and Herpes Zoster
- Patients with amputation and/or severe peripheral vascular disease (peripheral
revascularization interventions needed, AOCP> stage II, rheumatologic disorders
affecting arteriole or microcirculation)
- Patient with history of spinal cord surgery
- Patient with history of chronic alcoholism
- Concomitant use of pharmacological agents which can cause neuropathic pain as an
adverse event, except for chemotherapy
- Patient who already experienced acupuncture for any condition
- Patient currently in treatment with duloxetine, gabapentin, pregabalin or other
drugs for the treatment of neuropathic pain
- Patient with history of psychiatric disorders before breast cancer diagnosis (major
depressive disorders, bipolar disorder, suicidal tendency)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Claudio Zamagni, MD
Phone:
051 2144548
Phone ext:
+39
Email:
zamagniclaudio.sper@aosp.bo.it
Facility:
Name:
Fondazione Policlinico Universitario A. Gemelli IRCCS Center for Integrative Oncology
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefano Magno, MD
Phone:
0630157077
Phone ext:
+39
Email:
stefano.magno@policlinicogemelli.it
Start date:
September 1, 2020
Completion date:
December 2023
Lead sponsor:
Agency:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agency class:
Other
Collaborator:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673746
